Lower risk Drug recall · FDA · Published October 31, 2023

LEADER Dry Eye Relief Product Recall: Non-Sterile Risk

Cardinal Health recalls LEADER Dry Eye Relief (0.33 fl oz) due to non-sterility found at manufacturing facility. FDA detected bacterial contamination in environmental samples.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0135-2024Drug LEADER ›

Lower-risk recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Take action

Contact the company

Recalling firmCardinal Health Inc.7000 Cardinal Pl · Dublin, OH 43017-1091

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling LEADER Dry Eye Relief eye drops because the manufacturing facility had unsanitary conditions and bacterial contamination. This poses a risk of infection from using the product. Read more at govinfonow.com/recall/33019-leader-dry-eye-relief-product-recall-non-sterile-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33019-leader-dry-eye-relief-product-recall-non-sterile-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0135-2024

Cite this page

“LEADER Dry Eye Relief Product Recall: Non-Sterile Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33019-leader-dry-eye-relief-product-recall-non-sterile-risk. Based on FDA recall #D-0135-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0135-2024%22&limit=1).

Cardinal Health Inc. recalled LEADER brand Dry Eye Relief dropper bottles on Oct. 31, 2023, after the FDA found non-sterile conditions at its manufacturing facility. The Food and Drug Administration announced the Class I recall due to positive bacterial test results from environmental sampling.

How to tell if you have it

LEADER brand Dry Eye Relief
Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%
0.33 FL OZ (10 mL) dropper bottle
NDC: 70000-0088-1
ALL LOTS

The hazard

The FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. The product is classified as Class I, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Cardinal Health Inc. has 11 other recalls on record since 2018-11-16. Other recent recalls of similar products include Clear Eyes Eye Drops Recalled for Sterility Risk (2026-07-29), K.C. Pharmaceuticals Dry Eye Relief Eye Drops Recall: Lack of Sterility Assurance (2026-03-03), and Clear Eyes Eye Drops Recall: Lack of Sterility Risk (2026-09-15).

How to tell if you have this one

Check for LEADER brand Dry Eye Relief eye drops in 0.33 fl oz (10 mL) dropper bottles. The product was distributed by Cardinal Health in Dublin, Ohio and made in India. All lots are affected.

Brand
LEADER
Category
Drug

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-0131-2024	LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1; ALL LOTS	11629 units	70000-0087-1
D-0132-2024	LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1; ALL LOTS	21,802 bottles	70000-0089-1
D-0133-2024	LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1; ALL LOTS	119,871 bottles	70000-0090-1, 70000-0090-2
D-0134-2024	LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle); ALL LOTS	28477 cartons	70000-0090-1, 70000-0090-2
D-0135-2024	LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1; ALL LOTS	11,782 bottles	70000-0088-1
D-0136-2024	LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1; ALL LOTS	8,784 bottles	—

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the LEADER brand, 0.33 fl oz (10 mL) dropper bottle, and NDC 70000-0088-1 on the label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Oct 31, 2023Firm started the recall
Nov 29, 2023Published in FDA’s Enforcement Report
Dec 1, 2023FDA classified it Class I

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/33019-leader-dry-eye-relief-product-recall-non-sterile-risk">LEADER Dry Eye Relief Product Recall: Non-Sterile Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0135-2024 (October 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0135-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.